Belgian Screening Project for the Detection of Anderson-Fabry Disease in Hypertrophic Cardiomyopathy

Tracking Information
First Submitted Date	August 31, 2010
First Posted Date	September 10, 2010
Last Update Posted Date	January 12, 2012
Study Start Date	July 2009
Actual Primary Completion Date	August 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: May 30, 2011)	Determination of the prevalence of Fabry mutations in patients with left ventricular hypertrophy (moderate to severe), as measured by echocardiography [ Time Frame: At baseline T0 ]; patients with left ventricular hypertrophy will be screened for Fabry mutations, and results will be communicated within four months
Original Primary Outcome Measures; (submitted: September 8, 2010)	Determination of the prevalence of Fabry mutations in patients with left ventricular hypertrophy (moderate to severe), as measured by echocardiography; patients with left ventricular hypertrophy will be screened for Fabry mutations, and results will be communicated within four months
Change History	Complete list of historical versions of study NCT01198899 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Belgian Screening Project for the Detection of Anderson-Fabry Disease in Hypertrophic Cardiomyopathy
Official Title	Belgian Screening Project for the Detection of Anderson-Fabry Disease in Hypertrophic Cardiomyopathy
Brief Summary	The purpose of this study is to determine the prevalence of Fabry mutations in patients with left ventricular hypertrophy (moderate to severe), as measured by echocardiography.This study is a screening study
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	patients with left ventricular hypertrophy
Condition	Left Ventricular Hypertrophy
Intervention	Other: blood sampling; Blood sampling will be used.
Study Groups/Cohorts	left ventricular hypertrophy; Patients with left ventricular hypertrophy will be used.; Intervention: Other: blood sampling
Publications *	Terryn W, Deschoenmakere G, De Keyser J, Meersseman W, Van Biesen W, Wuyts B, Hemelsoet D, Pascale H, De Backer J, De Paepe A, Poppe B, Vanholder R. Prevalence of Fabry disease in a predominantly hypertensive population with left ventricular hypertrophy. Int J Cardiol. 2013 Sep 10;167(6):2555-60. doi: 10.1016/j.ijcard.2012.06.069. Epub 2012 Jul 16.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: January 11, 2012)	540
Original Estimated Enrollment; (submitted: September 8, 2010)	1000
Actual Study Completion Date	August 2011
Actual Primary Completion Date	August 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria	Inclusion Criteria: All patients over 18 years undergoing a routine echocardiography in the participating hospitals; Both genders will be considered.; Patients can be included if on 2D echocardiography the maximal septal wall thickness > 13 mm and/or the posterior wall thickness > 13 mm. The limit for inclusion is kept relatively low to detect early forms of Fabry cardiomyopathy.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Belgium
Removed Location Countries
Administrative Information
NCT Number	NCT01198899
Other Study ID Numbers	2009/035
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	University Hospital, Ghent
Study Sponsor	University Hospital, Ghent
Collaborators	Not Provided
Investigators	Principal Investigator: Raymond Vanholder, MD, PhD University Hospital Ghent, Belgium
PRS Account	University Hospital, Ghent
Verification Date	January 2012